From the blog

Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy

Published: February 24, 2016


Primary Outcome Measures
  1. Progression-free survival [ Time Frame: Baseline up to 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures
  1. Overall survival [ Time Frame: Baseline up to 3 years ] [ Designated as safety issue: No ]
  2. Frequency of responses [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  3. Toxicity [ Time Frame: Baseline up to 3 years ] [ Designated as safety issue: Yes ]


Inclusion Criteria
  1. Histologically confirmed malignant pleural mesothelioma meeting 1 of the following cell types:
    Mixed type
    Histologically documented malignant pleural mesothelioma, epithelial, sarcomatoid or mixed type, not amenable to surgical resection
    Prior Treatment
  2. Currently receiving first-line treatment with pemetrexed + platinum; patients are to be registered to Cancer and Leukemia Group B (CALGB) 30901 no later than the last day of cycle 4 of first line therapy
  3. Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) are acceptable; prior intrapleural cytotoxic chemotherapy will not be considered systemic chemotherapy
  4. Prior surgical treatment is allowed
  5. Prior radiation therapy is allowed
    Non-pregnant and non-nursing; women of child bearing potential and men must agree to use an appropriate method of birth control throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier methods (diaphragm plus condom)
    Patients with complete response, partial response, or stable disease following 4, 5 or 6 cycles of first-line chemotherapy with pemetrexed AND either cisplatin or carboplatin; a maximum of 6 cycles of chemotherapy may have been given
    Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
    Granulocytes >= 1,500/ul
    Platelet count >= 100,000/ul
    Total bilirubin =< 1.5 x upper limit of normal (ULN)
    Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2 x ULN Calculated creatinine clearance >= 45 ml/min
  6. Disease not amenable to surgery
  7. Must be enrolled on imaging protocol CALGB-580903
  8. Complete response, partial response, or stable disease after completion of 4 courses of first-line chemotherapy comprising pemetrexed disodium AND cisplatin or carboplatin
    Study therapy will begin within 9 weeks following day 1 of cycle 4 of first-line treatment
  9. No clinically significant pleural or peritoneal effusions that cannot be adequately managed by drainage before or during pemetrexed disodium
Patient Characteristics
  1. ECOG performance status of 0-1
  2. Life expectancy ≥ 12 weeks
  3. Granulocytes ≥ 1,500/μL
  4. Platelet count ≥ 100,000/μL
  5. Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  6. AST ≤ 2 times ULN
  7. Creatinine clearance ≥ 45 mL/min
  8. Not pregnant or nursing
  9. Negative pregnancy test
  10. Fertile patients must use effective contraception
  11. No psychiatric illness that would prevent the patient from giving informed consent
  12. No second malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix unless curatively treated with no evidence of active disease for ≥ 5 years
  13. No medical conditions that, in the opinion of the treating physician, would make study treatment unreasonably hazardous for the patient including, but not limited to, the following:
    Ongoing or active infection such as HIV positivity
    Inability to take oral medications
    Psychiatric illness/social situations that would limit compliance with study requirements
Contact Us
Have you received a diagnosis? *